Cleared Special

K000100 - CAMLOG ROOTFORM IMPLANT SYSTEM

K000100 is an FDA 510(k) clearance for CAMLOG ROOTFORM IMPLANT SYSTEM, manufactured by Altatec Biotechnologies. The device is a Class 2 Dental device with product code DZE cleared through the Special 510(k) pathway after a 15-day FDA review.

K000100 · Altatec Biotechnologies · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2000
Decision
15d
Days
Class 2
Risk

K000100 is an FDA 510(k) clearance for the CAMLOG ROOTFORM IMPLANT SYSTEM. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Altatec Biotechnologies (Potomac, US). The FDA issued a Cleared decision on January 28, 2000 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3640 - the FDA dental device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Altatec Biotechnologies devices

FDA 510(k) Submission Details - K000100

510(k) Number K000100 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 2000
Decision Date January 28, 2000
Days to Decision 15 days
Submission Type Special
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
112d faster than avg
Panel avg: 127d · This submission: 15d
Pathway characteristics
Modification to existing cleared device.

DZE Device Classification - Class 2, Special Controls

Product Code DZE Implant, Endosseous, Root-form
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3640
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - DZE Implant, Endosseous, Root-form

All 1104
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K000100.
LIFECORE SINGLE TOOTH ABUTMENT SYSTEM
K993894 · Lifecore Biomedical, Inc. · Mar 2000
DENTAL IMPLANT
K992937 · Nobel Biocare Uas, Inc. · Feb 2000
MODIFICATION OF REGULAR DIAMETER SINGLE STAGE (RDS) TPS DENTAL IMPLANT SYSTEM
K994205 · Lifecore Biomedical, Inc. · Feb 2000
MAGNA ABUTMENT
K984297 · Factor, Ii, Inc. · Jan 2000
NOBEL BIOCARE'S MODIFIED SURFACE IMPLANT (INTENDED FOR IMMEDIATE LOADING UPON PLACEMENT)
K993595 · Nobel Biocare Uas, Inc. · Jan 2000
THE 4.5MM DIAMETER BICON DENTAL IMPLANT
K994037 · Bicon, Inc. · Jan 2000